Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000192583
Ethics application status
Approved
Date submitted
23/05/2006
Date registered
24/05/2006
Date last updated
21/09/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase IIa safety study of topical R-flurbiprofen in patients with a history of non-melanoma skin cancer
Scientific title
A randomised, double blind, placebo controlled, Phase IIa study of the safety of R-flurbiprofen administered as a topical gel to patients with a history of non-melanoma skin cancer
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-melanoma skin cancer 1167 0
Condition category
Condition code
Cancer 1252 1252 0 0
Non melanoma skin cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial will assess the safety and tolerability of a topical gel containing 1% R-flurbiprofen, when applied to the skin of subjects with a history of non-melanoma skin cancer. This will be a double-blind, randomised, placebo-controlled trial. Thirty subjects will receive the R-flurbiprofen gel. The gel will be applied topically once daily, for 28 consecutive days, to the face, ears, neck, forearms and hands.
Intervention code [1] 1068 0
Prevention
Comparator / control treatment
10 will receive a placebo gel
Control group
Placebo

Outcomes
Primary outcome [1] 1690 0
This is a safety and tolerability trial of a topically-applied gel. The primary outcome will be skin irritation at the sites of administration.
Timepoint [1] 1690 0
Assessments will be conducted after 1, 2 and 4 weeks of application.
Secondary outcome [1] 3031 0
Adverse events
Timepoint [1] 3031 0
Assessed throughout the trial
Secondary outcome [2] 3032 0
Systemic absorption of R-flurbiprofen
Timepoint [2] 3032 0
Assessed at weeks 2 and 4.

Eligibility
Key inclusion criteria
Must have had at least one non-melanoma skin cancer in the past 5 years.
Minimum age
40 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any significant medical disorder;Current use of NSAIDs (and unwilling to cease use).

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Nil
Phase
Phase 2
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1366 0
Commercial sector/Industry
Name [1] 1366 0
PharmaQest Pty Ltd
Country [1] 1366 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
PharmaQest Pty Ltd
Address
Reid Building, UniSA
Frome Road
Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 1206 0
None
Name [1] 1206 0
Nil
Address [1] 1206 0
Country [1] 1206 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
This Phase IIa trial will assess the safety and tolerability of a topical gel containing 1% R-flurbiprofen, when applied to the skin of subjects with a history of non-melanoma skin cancer. This will be a double-blind, randomised, placebo-controlled trial. All subjects and study personnel will be blinded, except for the person allocating the active or placebo tubes to each subject, based on the randomisation schedule. Thirty subjects will receive the R-flurbiprofen gel, and 10 will receive a placebo gel. The gel will be applied topically once daily, for 28 consecutive days, to the face, ears, neck, forearms and hands.
The primary outcome measure will be skin irritation at the site of gel application.
Lay statement: This trial will test the safety of a gel when applied to the skin of people who have had at least one non-melanoma skin cancer. A future trial will test if this gel can prevent, or reduce the occurrence of, non-melanoma skin cancer.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35169 0
Address 35169 0
Country 35169 0
Phone 35169 0
Fax 35169 0
Email 35169 0
Contact person for public queries
Name 10257 0
Dr Peter Wigley
Address 10257 0
PharmaQest
Reid Building, University of South Australia
Frome Road
Adelaide SA 5000
Country 10257 0
Australia
Phone 10257 0
+61 8 83021224
Fax 10257 0
Email 10257 0
[email protected]
Contact person for scientific queries
Name 1185 0
Dr Peter Wigley
Address 1185 0
PharmaQest
Reid Building, University of South Australia
Frome Road
Adelaide SA 5000
Country 1185 0
Australia
Phone 1185 0
+61 8 83021224
Fax 1185 0
Email 1185 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.